Data / Medical devices / United States / Trinity Medical Devices Inc.
Trinity Medical Devices Inc.: FDA-registered device maker in Morristown, NJ, United States, 2 510(k) clearances
Trinity Medical Devices Inc. is registered with the FDA (registration 3010042047) in Morristown, NJ, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 24, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010042047
- Address
- 43 Speedwell Ave., #1251, Morristown, NJ, United States, 07960
- Owner or operator
- Trinity Medical Devices Inc. (10043038)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 21, 2013
- Registered through
- 2026
- Brand names listed
- NeoGuard Thermal Reflector, Trinity Medical Devices
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Complaint file establishment | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Complaint file establishment | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Complaint file establishment | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2009 | K091185 | 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Hsiner Co., Ltd. | accessdata.fda.gov |
| February 23, 2007 | K063268 | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 | BZD | Substantially Equivalent | Hsiner Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laryngoscope, Rigid
- All makers of Tape And Bandage, Adhesive
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Filter, Bacterial, Breathing-Circuit
Updated July 24, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.